Welcome to our dedicated page for Innovent Biologi news (Ticker: IVBIY), a resource for investors and traders seeking the latest updates and insights on Innovent Biologi stock.
The news feed for INNOVENT BIOLGCS UNSP/ADR (IVBIY) aggregates company press releases and media updates from Innovent Biologics, Inc., a biopharmaceutical company focused on oncology, cardiovascular and metabolic, autoimmune and ophthalmology diseases. These announcements provide insight into clinical trial progress, regulatory milestones, product approvals and corporate strategy that can influence how investors and observers view IVBIY.
Recent news highlights include multiple updates on mazdutide, a dual GCG/GLP-1 receptor agonist licensed from Eli Lilly for development in China. Innovent has reported National Medical Products Administration approvals for mazdutide in chronic weight management for adults with overweight or obesity and for glycemic control in adults with type 2 diabetes, along with Phase 3 data from the GLORY and DREAMS clinical programs. Other cardiovascular and metabolic pipeline news covers tigulixostat, a xanthine oxidase inhibitor for gout, and IBI3032, an oral GLP-1 receptor agonist with U.S. FDA IND approval for Phase 1 trials.
Oncology news items describe the development of IBI363, a PD-1/IL-2α-bias fusion protein, including U.S. FDA clearance of an IND for a global Phase 3 trial in immunotherapy-resistant squamous non-small cell lung cancer and data presented at major oncology conferences. Additional coverage includes IBI343, an anti-CLDN18.2 ADC with Phase 1 results in gastric/gastroesophageal junction adenocarcinoma published in Nature Medicine and the launch of multi-regional Phase 3 studies.
Investors following IVBIY can use this page to review updates on Innovent’s broader pipeline, such as picankibart for psoriasis, IBI324 for retinal diseases, and other marketed products mentioned in interim results and R&D day communications. Bookmark this news section to monitor how clinical data releases, regulatory decisions and partnership announcements may shape the company’s long-term development and commercialization plans.
Innovent Biologics has successfully dosed the first patient in a Phase 2 clinical trial for IBI112, an anti-interleukin 23 monoclonal antibody, aimed at treating moderate-to-severe plaque psoriasis. This trial, the first of its kind for domestic IL-23p19 inhibitors in China, seeks to evaluate the efficacy and safety of IBI112. With approximately 6 million psoriasis patients in China, the trial represents a significant advancement for patients seeking effective treatment options. The promising Phase 1 results highlight IBI112's safety profile and its potential for improved treatment adherence.
Innovent Biologics announced that the NMPA of China has accepted the supplemental New Drug Application for Sintilimab in combination with chemotherapy for treating esophageal squamous cell carcinoma (ESCC). This application is based on positive interim results from the Phase 3 ORIENT-15 clinical trial, which showed significant overall survival improvement. Esophageal cancer remains a major health concern in China, with Sintilimab representing a potential new treatment option. Innovent aims to expedite the review process for this regimen to address the urgent clinical need in ESCC patients.
Innovent Biologics reported interim analysis results from the Phase 3 ORIENT-16 study of sintilimab combined with chemotherapy for advanced gastric cancer. As of June 20, 2021, 650 patients were enrolled. Results showed a 34% reduction in death risk with median overall survival improving by 5.5 months in patients meeting specific criteria. Sintilimab's safety profile remained consistent with previous studies. The company plans to file for a supplemental drug application in China, aiming to provide a new treatment option for gastric cancer, which has a poor prognosis globally.
Innovent Biologics announced positive interim results from the Phase 3 ORIENT-15 study, presented at ESMO 2021, validating sintilimab's efficacy when combined with chemotherapy for esophageal squamous cell carcinoma (ESCC). The study achieved all endpoints: a median overall survival (mOS) of 16.7 months versus 12.5 months for the placebo group, and a median progression-free survival (mPFS) of 7.2 months versus 5.7 months. Sintilimab's safety profile was consistent with earlier studies. The company has submitted an application to the NMPA in China to secure first-line treatment approval for ESCC.
Innovent Biologics announced results from a Phase 2 study of pemigatinib in advanced cholangiocarcinoma patients at the ESMO Congress 2021. The study enrolled 34 subjects, revealing a 50% objective response rate (ORR) among 30 efficacy-evaluable participants. With a median follow-up of 5.13 months, the disease control rate was 100%. Safety analysis indicated that all subjects experienced treatment-related adverse events, with hyperphosphatemia (73.5%) as the most common. The New Drug Application for pemigatinib is under review in China, following approval in Taiwan.
Innovent Biologics has initiated a phase 2 clinical trial for IBI362, a dual agonist targeting GLP-1R and GCGR, for treating type 2 diabetes in China. The trial (NCT04965506) aims to assess IBI362's efficacy and safety compared to placebo and dulaglutide, focusing on HbA1c level changes over 20 weeks. Preliminary phase Ib results show a favorable safety profile and promising preliminary efficacy. IBI362 is licensed from Eli Lilly and may offer enhanced weight loss and metabolic benefits, appealing in a market where diabetes prevalence is 11.6% among adults in China.
Innovent Biologics and GenFleet Therapeutics have entered into an exclusive license agreement for the development and commercialization of GenFleet's KRAS G12C candidate, GFH925, in China and beyond. GFH925 has received Investigational New Drug approval in China and shows potential as a best-in-class treatment. Innovent will oversee clinical development in China and can pursue global commercialization. GenFleet will receive a $22 million upfront payment, with additional potential milestone payments totaling $290 million tied to development and sales success.
Innovent Biologics reported impressive interim results for the first half of 2021, achieving total revenue of RMB1,941.8 million, up 97.3% year-over-year driven by a doubling of product revenue to RMB1,854.6 million. The firm expanded its commercial portfolio from four to five products, thanks to the approval of PEMAZYRE® in Taiwan. Continuously growing revenue from TYVYT® and new products contributed significantly to their success. Innovent's pipeline now boasts 25 high-value assets, with six in pivotal trials, marking a strong trajectory for future growth.
Innovent Biologics announced the publication of phase 1b study results for IBI362, a dual agonist targeting GLP-1R and GCGR, in the journal EClinicalMedicine. This milestone is significant as it marks the first phase 1 clinical study from China in the metabolism field published in a Lancet journal. The study demonstrated substantial weight loss and multiple metabolic benefits, including improvements in blood pressure, lipids, and liver enzymes. IBI362 showed a favorable safety profile with no serious adverse events, suggesting potential as a novel treatment for obesity and type 2 diabetes.
Innovent Biologics announced on Aug. 15, 2021, that its sintilimab Phase 3 ORIENT-16 study achieved its primary endpoint, demonstrating significant improvement in overall survival for patients with advanced gastric cancer when combined with chemotherapy. This study is notable as it is the first Phase 3 trial in China showing an anti-PD-1 antibody's effectiveness in this setting. Innovent plans to file a supplemental new drug application based on the results, which are expected to provide a new treatment option for a patient population with limited options.
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